Condition category
Respiratory
Date applied
22/10/2008
Date assigned
31/10/2008
Last edited
04/03/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rob Stockley

ORCID ID

Contact details

Lung Investigation Unit
First Floor
Nuffield House
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

030547

Study information

Scientific title

Evaluation of the relative severity of pulmonary neutrophilic inflammation and therapeutic modification with intravenous prolastin by means of 18 fluoro-2-deoxyglucose (18FDG) positron emission tomography (PET)/computerised tomography (CT) scanning in subjects with usual chronic obstructive pulmonary disease (COPD) and alpha 1-antitrypsin deficiency

Acronym

ECLIPSE-AATD

Study hypothesis

18 fluoro-2-deoxyglucose (18FDG) positron emission tomography (PET)/computerised tomography (CT) scanning will enable non-invasive in vivo assessment of global neutrophilic inflammation in the lungs that relates to recognised biomarkers. It is anticipated that the level of lung inflammation will be highest in subjects with alpha 1-antitrypsin deficiency and lowest in healthy controls. Furthermore, it is anticipated that, following a 12-week treatment period of alpha 1-antitrypsin augmentation with intravenous (IV) prolastin, there will be a reduction in pulmonary inflammation that will be quantifiable with reference to subjects with usual chronic obstructive pulmonary disease (COPD) and healthy controls.

Ethics approval

The study was approved by the Hammersmith and Queen Charlotte's and Chelsea REC on 08/08/2008 (ref: 08/H0707/46).

Study design

Interventional single-arm trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.

Condition

Chronic obstructive pulmonary disease (COPD), emphysema, alpha 1-antitrypsin deficiency

Intervention

This is a proof of principle study. Study patients will acts as own controls by comparison between pre- and post-treatment measurements, and inter-group comparisons. Only those patients with alpha 1-antitrypsin deficiency will be treated with intravenous infusion of prolastin at a dose of 60 mg/kg per week for 12 consecutive weeks.

Please use the following contact details to request a patient information sheet:
Dr Anita Pye
Lung Investigation Unit
First Floor, Nuffield House
Queen Elizabeth Hospital
Edgbaston B15 2TH
Birmingham
United Kingdom
Tel +44 (0)121 697 8256
Email: anita.pye@uhb.nhs.uk

Intervention type

Drug

Phase

Not Specified

Drug names

Prolastin

Primary outcome measures

Quantitative PET/CT using Patlak plots of uptake of 18FDG by lung tissue as a surrogate measure of pulmonary neutrophilic inflammation.

Primary and secondary outcome measures will be compared between groups at baseline. Only those patients with alpha 1-antitrypsin deficiency will be treated with prolastin, and comparison will be made between baseline and end of treatment values, within one week of treatment completion.

Secondary outcome measures

1. Other biomarkers obtained from sputum, whole blood and plasma
2. Relationship between emphysema severity and neutrophilic inflammation by inter-individual and intra-individual comparisons

Primary and secondary outcome measures will be compared between groups at baseline. Only those patients with alpha 1-antitrypsin deficiency will be treated with prolastin, and comparison will be made between baseline and end of treatment values, within one week of treatment completion.

Overall trial start date

01/11/2008

Overall trial end date

01/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy controls:
1. Healthy subjects
2. Both males and females, aged 50 - 70 years
3. Those who have never smoked regularly for more than 3 months
4. No evidence of lung disease
5. Forced expiratory volume in 1 second (FEV1) greater than 75% predicted, FEV1/forced vital capacity (FVC) greater than 70% predicted
6. No relevant medical or mental disorder
7. Able to give informed consent

COPD patients:
1. Emphysema with no other active lung disease
2. FEV1 less than 75% predicted, FEV1/FVC less than 70% predicted, carbon monoxide transfer coefficient (KCO) less than 80% predicted (or known emphysema on previous CT scan)
3. Fewer than two acute exacerbations in the previous 12 months and no recent exacerbations (within 2 months)
4. No other relvant medical or mental disorder
5. Able to give informed consent

Patients with alpha 1-antitrypsin deficiency:
1. PiZ phenotype
2. Emphysema with no other active lung disease
3. FEV1 less than 75% predicted, FEV1/FVC less than 70% predicted, KCO less than 80% predicted (or known emphysema on previous CT scan)
4. Fewer than two acute exacerbations in the previous 12 months and no recent exacerbations (within 2 months)
5. No other relvant medical or mental disorder
6. Able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/11/2008

Recruitment end date

01/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lung Investigation Unit
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

University Hospitals Birmingham NHS Foundation Trust (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhb.nhs.uk

Funders

Funder type

Government

Funder name

Department of Health (UK) - Technology Platform Grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Talecris Biotherapeutics (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22837375

Publication citations

  1. Results

    Subramanian DR, Jenkins L, Edgar R, Quraishi N, Stockley RA, Parr DG, Assessment of pulmonary neutrophilic inflammation in emphysema by quantitative positron emission tomography., Am. J. Respir. Crit. Care Med., 2012, 186, 11, 1125-1132, doi: 10.1164/rccm.201201-0051OC.

Additional files

Editorial Notes